Regional Epidemiology & Health Economics ISS GSS Study Coordinator

Job description

Details:

Job Purpose:

To assist the Regional Epidemiology & Health Economics Team with the administration and coordination of EPI and HE investigator-led studies (ISS) as well as GSK-sponsored studies (GSS) in the Emerging Markets Region according to company process documents, GCP-ICH, and Good Pharmacoepidemiology Practices (GPP) guidelines, so that the results are acceptable locally and internationally.

Key Responsibilities:

- Support for operational study related activities
o Supports the internal and external approval processes and applications to conduct ISS/GSS studies.
o Provides the EPI/HE team with study-related progress reports.
o Ensures high quality and up-to-date information in the company specific planning and tracking tools for studies.
o Follows-up with study team members (PDL, SDL, Statistician, Data Manager, Scientific Writer, LOC Medical Affairs, LDL, and others…) to resolve any potential study-related discrepancies as needed and escalates any issue to the Regional Epidemiologist and/or Health Economist and/or Regional EPI/HE Lead for mutual problem solving.
o For ISS EPI studies, verifies that in POMS, all the study-related documents are archived according to company process documents, and helps to archives these if needed by connecting with the study accountable person, LOC Medical Affairs, and/or the investigator (For GSS EPI studies, verifies that all the study-related documents are archived that in eTMF).
o For HE studies, verifies that the study-related documents are archived in TrackHO according to company process documents, and helps to archives these if needed.
o Conducts Level 1 QC of study essential documents in POMS, TrackHO, and eTMF, and makes sure that the EPI/HE study files are audit-ready.
o Supports the study budgeting by supporting the budget review process for ISS studies, and the Study Budget Breakdown (SBB) process for GSS studies. Follows-up and reviews study invoices & payments and monitors the expenses on regular basis versus forecasts. Provides support in resolution of deviations/issues in actual expenses and escalate if required.
o Supports the study contracting process, as well as the ABAC process related to research partners and investigators.
o Provides support for updating the regional risk management register.
o Helps to prepare slides for Medical Affairs Streams' strategic review of study proposals and for the technical/scientific review of proposals at the VEHRC.
o Provides support for the preparation of operational meetings; e.g. workshops on process improvements for local EPI/HE evidence generation activities, and other, as appropriate.
o Participates and provides support in study specific meetings (e.g. 2-monthly TC with CMLs,…).
o Participates actively in designing/coming up with improvements of ways of working and in innovations related to local data generation activities.
o Interacts with team members and regional colleagues to share best practices, lessons learned, and implementation of improvements related to local data generation activities.
o Provides support in organizing educational & scientific webinars on at-need basis

Our Offer:

At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.

The department:

Patient-focused Research and Development (R&D) is the heart of our business. Our R&D department seeks to discover and develop new vaccines, to protect against diseases where vaccines are not yet available and to improve on those vaccines that already exist. Part of our R&D programme targets diseases particularly prevalent in the developing world, including the World Health Organisation's three priority diseases - HIV/AIDS, tuberculosis and malaria. Research into candidate vaccines for other diseases of the developing world, such as dengue are at an earlier stage of development.
When it comes to developing the vaccines of the future, we're looking for real experts in their respective fields who are interested in working in the stimulating environment of an international healthcare company.
We emphasise the value of teamwork and we look for people ready to share our values of transparency, respect, integrity and patient focus.

Our Company:

GSK is a science-led global healthcare company with a mission to help people do more, feel better, live longer. At GSK, we research, manufacture and make available a broad range of medicines, vaccines and consumer healthcare products.

GSK Vaccines is a world's leading company, involved in vaccine research, development and production. We have 16 candidate vaccines in development and our broad portfolio of around 40 vaccines prevent illnesses such as hepatitis A, hepatitis B, diphtheria, tetanus, whooping cough, measles, mumps, rubella, polio, typhoid, influenza and bacterial meningitis. Globally, we have more than 16.000 people working to deliver vaccines safely, every day, to people in 90% of the world's countries. In 2014 we distributed around 800 million doses of vaccine, 80% of them to least developed, low and middle income countries.
For further information, please visit www.gsk.com.
GSK Consumer Healthcare produces a range of consumer health products based on scientific innovation. They develop and market a range of products in the areas of: Pain Relief, Respiratory, Oral Health, Nutrition/Gastro Intestinal and Skin Health. These include a number of well-known brands such as Sensodyne, Paradontax, Poligrip, Voltaren, Panadol, Otrivin and Theraflu.

GSK Pharmaceuticals includes research, development and manufacture of medicines for a variety of serious and chronic diseases. This includes market leading products for Respiratory, Anti-Viral, Central Nervous System, Cardiovascular and Urogenital, Anti-Bacterial, Oncology and HIV.

*LI-GSK

Contact information:

You may apply for this position online by selecting the Apply now button.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Desired profile

Basic qualifications:

Profile:

- Graduate or Bachelor level with relevant working experience in pharmaceutical / scientific environment.
- Scientific background or deep knowledge and working experience on clinical trials or on epidemiology studies from the phase of setting-up until the phase of closure/archiving studies (including being familiar with ICH-GCP, regulatory and legal requirements for human subject research).

Preferred qualifications:

- Knowledge and scientific background in Epidemiology (EPI) and Health Economics (HE) studies/research is an asset.
- Experience in direct coordination with investigators based in developing, as well as developed countries.
- Experience in project management.
- Familiarity with finance and accounting principles in order to understand budget, invoices, cross-charges and expense reports.
- Experience of working in a multi-cultural environment
- Ability to work effectively with remote stakeholders.
- Detail-oriented.
- Proactive – flexible.
- Team spirit.
- Independent worker.
- Problem solver.
- Good communication skills (oral & written).
- Time management skills, ability to clearly identify priorities and manage multiple tasks.
- Proficient in English (oral and written).
- Proficient with Microsoft Office (Excel, PowerPoint, Word, Outlook).
- Familiar with project management tools and techniques (like critical path analysis or network analysis, using MS Project…) is an asset.